An Examination of a Weight Loss Formula on Health (NB14)

• ClinicalTrials.gov Identifier: NCT03395262
• Recruitment Status: Completed
• First Posted: January 10, 2018
• Last Update Posted: September 10, 2019
• Sponsor: Texas A&M University
• Information provided by (Responsible Party): Richard B. Kreider, Texas A&M University

Study Description

Brief Summary:

The aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

Condition or disease	Intervention/treatment	Phase
Weight Loss	Dietary Supplement: Active with caffeine; Dietary Supplement: Active without caffeine; Dietary Supplement: Placebo	Not Applicable

Detailed Description:

Obesity remains a problem for overall health and risk for cardiovascular disease worldwide. While dietary modification and increased levels of physical activity remain steadfast recommendations, alternative strategies related to supplementation remain an interest for the general populace and medical communities. A potential objection to the use of dietary supplements is that they often contain stimulants designed to increase metabolism. However, consumers and health practitioners alike are wary of such formulae; hence, the continued investigation of non-stimulant supplements is warranted. Therefore the aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• Official Title: An Examination of a Novel Weight Loss Formula on Anthropometry and Indices of Cardiovascular Disease Risk
• Actual Study Start Date: June 1, 2017
• Actual Primary Completion Date: March 31, 2018
• Actual Study Completion Date: December 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active with caffeine; Novel formula with caffeine	Dietary Supplement: Active with caffeine; Novel formula with caffeine
Active Comparator: Active without caffeine; Novel formula without caffeine	Dietary Supplement: Active without caffeine; Novel formula without caffeine
Placebo Comparator: Placebo; Dextrose	Dietary Supplement: Placebo; Dextrose placebo

Outcome Measures

Primary Outcome Measures :

1. Body Composition - Weight [ Time Frame: Measured every 4 weeks for 12 weeks ]
   Changes in body weight (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
2. Body Composition - Fat Mass [ Time Frame: Measured every 4 weeks for 12 weeks ]
   Changes in fat mass (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
3. Body Composition - Body Fat Percent [ Time Frame: Measured every 4 weeks for 12 weeks ]
   Changes in body fat (%) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Secondary Outcome Measures :

1. Body Composition - Lean Tissue Mass [ Time Frame: Measured every 4 weeks for 12 weeks ]
   Change in lean tissue mass (kg) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
2. Body Composition - Bone Mass [ Time Frame: Measured every 4 weeks for 12 weeks ]
   Change in bone mass (g) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
3. Body Composition - Fat Free Mass [ Time Frame: Measured every 4 weeks for 12 weeks ]
   Changes in fat free mass (sum of lean tissue mass and bone mass expressed in kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
4. Body Composition - Total Body Water [ Time Frame: Measured every 4 weeks for 12 weeks ]
   Change in total body water (L and %) and analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
5. Resting Energy Expenditure - Caloric Expenditure [ Time Frame: Measured every 4 weeks for 12 weeks ]
   Change in resting energy expenditure expressed in absolute (kcals/d) and relative terms (kcals/kg/day) and analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
6. Resting Energy Expenditure - Respiratory Exchange Ratio [ Time Frame: Measured every 4 weeks for 12 weeks ]
   Change in resting respiratory exchange ratio (RER) as an indicator of carbohydrate and fat oxidation analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
7. Anthropometric Measures - Waist Circumference [ Time Frame: Measured every 4 weeks for 12 weeks ]
   Change in waist circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
8. Anthropometric Measures - Hip Circumference [ Time Frame: Measured every 4 weeks for 12 weeks ]
   Change in hip circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
9. Anthropometric Measures - Waist to Hip Ratio [ Time Frame: Measured every 4 weeks for 12 weeks ]
   Change in the ratio of waist to hip (waist / hip circumference) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
10. Anthropometric Measures - Body Mass Index [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in body mass index (kg of body mass / height in meters squared) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
11. Dietary Energy Intake - Total Caloric Intake [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in caloric/energy intake (kcals/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
12. Dietary Energy Intake - Carbohydrate [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in dietary carbohydrate intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
13. Dietary Energy Intake - Fat [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in dietary fat intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
14. Dietary Energy Intake - Protein [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in dietary protein intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
15. Resting Hemodynamics - Heart Rate [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Changes in resting heart rate (bpm) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
16. Resting Hemodynamics - Systolic Blood Pressure [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Changes in resting systolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
17. Resting Hemodynamics - Diastolic Blood Pressure [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Changes in resting diastolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
18. Blood Chemistry Markers of Health - Glucose Homeostasis - Blood Glucose [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in blood glucose (mg/dl) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
19. Blood Chemistry Markers of Health - Glucose Homeostasis - Fasting Insulin [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in fasting insulin (µIU/mL) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
20. Blood Chemistry Markers of Health - Glucose Homeostasis - Homeostatic Model Assessment of Insulin Resistance [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in Homeostatic Model Assessment of Insulin Resistance (Fasting insulin x Fasting glucose / 405) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
21. Blood Chemistry Markers of Health - Lipid Profile - Triglyderides [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in triglycerides (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
22. Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in total cholesterol (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
23. Blood Chemistry Markers of Health - Lipid Profile - High Density Lipoproteins [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in high density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
24. Blood Chemistry Markers of Health - Lipid Profile - Low Density Lipoproteins [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in low density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
25. Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol to HDL Ratio [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in the ratio of total cholesterol to high density lipoproteins (HDL) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
26. Blood Chemistry Markers of Health - Catabolic Markers - Creatinine [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
27. Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in blood urea nitrogen (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
28. Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen to Creatinine Ratio [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in the ratio of blood urea nitrogen (mg/dl) to creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
29. Blood Chemistry Markers of Health - Catabolic Markers - Alkaline Phosphatase [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in alkaline phosphatase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
30. Blood Chemistry Markers of Health - Catabolic Markers - Alanine Amino Transaminase [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in alanine amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
31. Blood Chemistry Markers of Health - Catabolic Markers - Aspartate Amino Transaminase [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in aspartate amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
32. Blood Chemistry Markers of Health - Catabolic Markers - Creatine Kinase [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in creatine kinase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
33. Blood Chemistry Markers of Health - Catabolic Markers - Lactate Dehydrogenase [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in lactate dehydrogenase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
34. Blood Chemistry Markers of Health - White Blood Cell Counts - White Blood Cells [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in white blood cells (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
35. Blood Chemistry Markers of Health - White Blood Cell Counts - Lymphocytes [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in lymphocytes (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
36. Blood Chemistry Markers of Health - White Blood Cell Counts - Mid-Range Count [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in mid-range count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
37. Blood Chemistry Markers of Health - White Blood Cell Counts - Granulocyte [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in granulocyte count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
38. Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cells [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in red cell count (M/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
39. Blood Chemistry Markers of Health - Red Blood Cell Counts - Hemoglobin [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in hemoglobin (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
40. Blood Chemistry Markers of Health - Red Blood Cell Counts - Hematocrit [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in hematocrit (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
41. Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Volume [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in mean corpuscular volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
42. Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in mean corpuscular hemoglobin (pg/cell) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
43. Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin Concentration [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in mean corpuscular hemoglobin concentration (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
44. Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cell Distribution Width [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in red cell distribution width (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
45. Blood Chemistry Markers of Health - Red Blood Cell Counts - Platelet Count [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in platelet count (x103/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
46. Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Platelet Volume [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in mean platelet volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
47. Blood Chemistry Markers of Health - Appetite Hormone - Leptin [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in leptin levels (ng/ml) analyzed via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
48. International Physical Activity Questionnaire (IPAQ) - Work Domain [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in IPAQ work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
49. International Physical Activity Questionnaire (IPAQ) - Active Transportation Domain [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in IPAQ active transportation domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
50. International Physical Activity Questionnaire (IPAQ) - Domestic and Garden/Yard Work Domain [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in IPAQ domestic and garden/yard work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
51. International Physical Activity Questionnaire (IPAQ) - Leisure-Time Domain [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in IPAQ leisure-time domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
52. International Physical Activity Questionnaire (IPAQ) - Total Physical Activity Score [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in IPAQ leisure time domain (Total physical activity MET-minutes/week = sum of Total Work + Total Transport + Total Domestic and Garden + Total Leisure-Time MET-minutes/week scores) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
53. Satiety Questionnaire - Perceptions of Appetite [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Changes in perceptions of appetite assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
54. Satiety Questionnaire - Perceptions of Hunger [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Changes in perceptions of hunger assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
55. Satiety Questionnaire - Perceptions of Satisfaction with Food [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Changes in perceptions of satisfaction with food assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
56. Satiety Questionnaire - Perceptions of Feelings of Fullness [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Changes in perceptions of feelings of fullness assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
57. Satiety Questionnaire - Perceptions of Diet / Eating Satisfaction [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Changes in perceptions of diet / eating satisfaction assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
58. Sleep Quality Questionnaire - Sleep Duration [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Changes in average reported sleep duration over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
59. Sleep Quality Questionnaire - Sleep Quality [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Changes in rating of sleep quality over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
60. Sleep Quality Questionnaire - Enthusiasm [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Changes in rating of enthusiasm over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
61. Sleep Quality Questionnaire - Sleep Disturbances [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Changes in rating of sleep disturbances over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
62. Perceptions of Side Effects - Dizziness [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in perceptions of dizziness using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
63. Perceptions of Side Effects - Headache [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in perceptions of headache using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
64. Perceptions of Side Effects - Tachycardia [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in perceptions of tachycardia using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
65. Perceptions of Side Effects - Palpitations [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in perceptions of palpitations using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
66. Perceptions of Side Effects - Dyspnea [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in perceptions of dyspnea using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
67. Perceptions of Side Effects - Nervousness [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in perceptions of nervousness using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
68. Perceptions of Side Effects - Blurred Vision [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in perceptions of blurred vision using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
69. Perceptions of Side Effects - Other Side Effects [ Time Frame: Measured every 4 weeks for 12 weeks ]
    Change in perceptions of other side effects using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Body Mass Index (BMI) between 25 and 34.9

Exclusion Criteria:

• Recent history of weight change (+/- 10 lbs. within the past 3 months)
• Uncontrolled metabolic disorders
• Uncontrolled cardiovascular disorders
• Currently taking prescription medications (birth control is allowed)
• Currently taking dietary supplements for weight loss
• Pregnant or plan to become pregnant
• Have an intolerance to caffeine or other natural stimulants

Contacts and Locations

Locations

United States, Texas

Exercise & Sport Nutrition Lab - Human Clinical Research Facility

College Station, Texas, United States, 77845

Sponsors and Collaborators

Texas A&M University

Investigators

• Principal Investigator: Richard B Kreider, PhD; Texas A&M University

More Information

• Responsible Party: Richard B. Kreider, Executive Director, Human Clinical Research Facility, Texas A&M University
• ClinicalTrials.gov Identifier: NCT03395262
• Other Study ID Numbers: IRB2016-0829FX
• First Posted: January 10, 2018
• Last Update Posted: September 10, 2019
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Body Weight; Weight Loss; Body Weight Changes; Caffeine; Central Nervous System Stimulants; Physiological Effects of Drugs; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Purinergic P1 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents